Leigh Eworonsky v. HHS - MMR, Autistic Disorder (AD); pervasive developmental disorder (PDD), not otherwise specified (2017)

Leigh Eworonsky, as parent of A.E., a minor, filed a petition on June 10, 2004, alleging that vaccinations, including the MMR, hepatitis A, and Varicella vaccines, caused A.E.'s Autistic Disorder and pervasive developmental disorder, not otherwise specified, through a post-vaccination developmental regression. The case was part of the Omnibus Autism Proceeding (OAP) and later consolidated into a "mini-omnibus" proceeding with 23 other cases to test the theory of causation involving residual human DNA fragments and HERV-K retrovirus elements in the MMR vaccine.

The lead case for this mini-omnibus was V.J.M. v. Secretary, and all petitioners agreed to be bound by its decision.

On August 31, 2017, Chief Special Master Nora Beth Dorsey issued a decision in the lead case, V.J.M., denying entitlement. This decision was reissued in redacted form on February 7, 2018.

The decision found that the petitioners' theory, which posited that residual human DNA fragments and HERV-K endogenous retrovirus elements in the MMR vaccine cause autism through insertional mutagenesis or autoimmunity, was not supported by preponderant evidence. Specifically, Dr.

Theresa Deisher's "change point" study, central to the petitioners' theory, was found to have significant methodological limitations, including an ecological study design, data accuracy issues, and flawed statistical analysis. The proposed mechanisms of action, such as retrograde transport and microvesicle transport, were deemed undeveloped or unsupported.

Dr. Deisher conceded that the role of HERV-K in disease was "observational" and unknown.

The decision also noted that numerous epidemiological studies overwhelmingly rejected the MMR-autism causal link. Following the decision in the lead case, A.E.'s petition was dismissed on August 31, 2017, based on the same reasoning.

The public decision for A.E.'s case incorporates the reasoning from the lead V.J.M. decision, although it does not reproduce A.E.'s specific clinical timeline. The petition was dismissed for insufficient proof.

Prior to the final dismissal, an interim decision regarding attorney fees and costs was issued on August 12, 2014, by Special Master Denise Kathryn Vowell, awarding $150.00 to Leigh Eworonsky and $18,879.53 jointly to Leigh Eworonsky and her attorney, Harry G. Potter, III.